StabiliT ER Bone Cement:
The StabiliT ER Bone Cement is intended for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

StabiliT Vertebral Augmentation System (for use with StabiliT ER * Bone Cement):
The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Description

StabiliT ER* Bone Cement:
The StabiliT ER Bone Cement is two-component PMMA bone cement with a powder component and a liquid component.

StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement):
StabiliT Vertebral Augmentation System is a motorized, microprocessor controlled bone cement delivery system intended for percutaneous delivery of bone cement in vertebroplasty or kyphoplasty procedures that allows for warming of the cement during cement delivery.

AI/ML Overview

This document describes the 510(k) premarket notification for the StabiliT ER Bone Cement and StabiliT Vertebral Augmentation System. While it confirms the device's substantial equivalence to predicate devices based on in-vitro testing and biocompatibility, it does not contain information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML product or a complex medical device undergoing extensive clinical trials for performance metrics.

Specifically addressing your numbered points based on the provided text:

A table of acceptance criteria and the reported device performance:
The document mentions "Results of in-vitro testing (material, performance, mechanical, electrical) demonstrate that the StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) functioned as intended and the results of tests were as expected." However, it does not provide a specific table of acceptance criteria or detailed quantitative performance metrics. It only states that the devices functioned as intended and meet the requirements of ISO 10993-1 for biocompatibility.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. The testing described is "in-vitro testing," which generally refers to laboratory tests, not human or animal clinical trials.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable/not provided as the testing was in-vitro (material, mechanical, electrical performance, biocompatibility) and did not involve expert-established ground truth for a diagnostic or AI/ML-driven device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/not provided for the same reasons as point 3.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable/not provided. The device in question is a bone cement and a delivery system for vertebroplasty/kyphoplasty. It is a physical medical device, not an AI/ML diagnostic or assistive technology that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. The device is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this type of device typically relates to engineering specifications and material science standards (e.g., tensile strength, setting time, biocompatibility standards). The document states the device "meet the requirements of ISO 10993-1" for biocompatibility and "functioned as intended" based on in-vitro material, performance, mechanical, and electrical testing. However, no specific details on the metrics or how "ground truth" was established are provided beyond these general statements.
The sample size for the training set:
This information is not applicable/not provided as the device is not an AI/ML product requiring a training set.
How the ground truth for the training set was established:
This information is not applicable/not provided as the device is not an AI/ML product requiring a training set.

Summary of Acceptance Criteria and Device Performance (as much as can be extracted):

Acceptance Criteria Category	Reported Device Performance	Study Type
Material Performance	Functioned as intended	In-vitro
General Performance	Functioned as intended	In-vitro
Mechanical Performance	Functioned as intended	In-vitro
Electrical Performance	Functioned as intended	In-vitro
Biocompatibility	Meets ISO 10993-1 requirements	In-vitro

Overall Study Information:

Study Name/Type: In-vitro testing (material, performance, mechanical, electrical, and biocompatibility).
Sample Size (Test Set): Not specified. (Applies to in-vitro samples of the cement and device components)
Data Provenance: Not specified, but generally refers to laboratory testing environment.
Experts for Ground Truth: Not applicable (in-vitro engineering and material testing).
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable (device is not an AI/ML diagnostic/assistive technology).
Standalone Performance: Not applicable (device is not an algorithm).
Type of Ground Truth: Adherence to established engineering specifications and material science standards (e.g., ISO 10993-1 for biocompatibility).
Sample Size (Training Set): Not applicable (device is not an AI/ML product).
Training Set Ground Truth Establishment: Not applicable.

The document primarily focuses on establishing "substantial equivalence" to predicate devices based on shared intended use, indications, technological characteristics, and principles of operation, supported by in-vitro tests that showed the device "functioned as intended" and met biocompatibility standards. It does not provide detailed performance metrics or clinical study results that typically accompany acceptance criteria for more complex medical devices or AI/ML products.

Summary

{0}------------------------------------------------

510(K) SUMMARY OR 510(K) STATEMENT ട.

K090986

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: 04/06/09

510(k) number: __

ﺎ

Applicant Information:

DFine Inc. 3047 Orchard Parkway San Jose, CA 95134, USA

Contact Person

Sandeep Saboo
Phone Number:	408-321-9999 ext 248
Fax Number:	408-321-9401
e-mail:	sandeeps@dfineinc.com

Device Information:

Trade Name:	StabiliT ER* Bone Cement
	StabiliT Vertebral Augmentation System
Classification:	Class II (StabiliT ER* Bone Cement)
	Class I (StabiliT Vertebral Augmentation System)
Classification Name:	Bone Cement
	Cement Dispenser

Physical Description:

StabiliT ER* Bone Cement

The StabiliT ER Bone Cement is two-component PMMA bone cement with a powder component and a liquid component.

StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement)

StabiliT Vertebral Augmentation System is a motorized, microprocessor controlled bone cement delivery system intended for percutaneous delivery of bone cement in vertebroplasty or kyphoplasty procedures that allows for warming of the cement during cement delivery.

Intended Use:

StabiliT ERA Bone Cement

The StabiliT ER Bone Cement is intended for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement) The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment

DFine Inc.

DEC 30 2009

{1}------------------------------------------------

of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Test Results:

Performance

Results of in-vitro testing (material, performance, mechanical, electrical) demonstrate that the StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) functioned as intended and the results of tests were as expected.

Biocompatibility

The materials used in the StabiliT ER' Bone Cement and StabiliT Vertebral Augmentation System (StabiliT ERA Bone Cement) meet the requirements of ISO 10993-1.

Substantial Equivalence and Summary:

The subject devices StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement) have the same intended use and indications, technological characteristics and principles of operation as their predicate, respectively, StabiliT ER Bone Cement (formerly known as SPACE CpsXL Bone Cement) [K072496] and SPACE 360 Delivery System (for use with SPACE CpsXL Bone Cement) [K070351] (also called StabiliT Vertebral Augmentation System).

The minor technological differences between StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) and their predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that StabiliT ER Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) are as safe and effective as the predicate devices for their intended use. Thus, StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement) are substantially equivalent to their marketed predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three faces in profile, suggesting a sense of community and diversity. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DFine Inc. % Mr. Sandeep Saboo 3047 Orchard Parkway San Jose, California 95134

DEC 30 2009

Re: K090986

Trade/Device Name: StabiliT ER Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) Regulation Number: 21 CFR 888.3027 Regulation Name: Polmethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, KIH Dated: December 17, 2009 Received: December 18, 2009

Dear Mr. Saboo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 – Mr. Sandeep Saboo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Daniel Kane

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K090986

Device Name: StabiliT ERX Bone Cement and

StabiliT Vertebral Augmentation System (for use with StabiliT ERX Bone Cement)

Indications for Use:

StabiliT ER Bone Cement:

The StabiliT ER Bone Cement is intended for the treatment of pathological fractures He Stablin E. ( Bertebroplasty or kyphoplasty procedure. Painful vertebral of the vertobrato acing a vertosit from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

StabiliT Vertebral Augmentation System (for use with StabiliT ER * Bone Cement):

Ochienty.
The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of The Otablir? Vortobrament in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression treathent of pathologiod fractaros onish benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of GDRH, Offjge of Device Evaluation (ODE)

RANDALL R. ARNOLD FOR M.MEUKERSON

Page _ of _

Division of Surgical, Orthopedic, and Restorative Devices

(Division Sign-Off)

K090986

DFine Inc.

Response to Deficiency Questions - K090986 Stork) Number StabiliT ER Bone Cement, and StabiliT Vertebral Augmentation System for use with StabiliT ER* Bone Cement Page 37

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”